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Protocol Details

Evaluation, Pathogenesis, and Outcome of Subjects with or Suspected Traumatic Brain Injury

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-N-0122

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Diffusion/Perfusion-MRI;
Magnetic Resonance Imaging (MRI);
Traumatic Brain Injury;
Brain Imaging;
Brain Injuries

Recruitment Keyword(s)

Traumatic Brain Injury;
TBI

Condition(s)

Traumatic Brain Injury

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and StrokeCenter for Neuroscience and Rehabilitation Medicine (CNRM)Department of DefenseHenry Jackson Foundation

Background:

- Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional and cognitive deficits that often go undetected during initial treatment. To improve treatments and therapies and to provide a uniform quality of care, researchers are interested in developing more standardized criteria for diagnosing and classifying different types of traumatic brain injury. By identifying imaging and other indicators immediately after the injury and during the initial treatment phrase, researchers hope to better understand the nature and effects of acute traumatic brain injury.

Objectives:

- To study the MRI results of individuals who have recently had head injury and suspected traumatic brain injury.

- To study the natural evolution of traumatic brain injury for up to 3 months after head injury.

Eligibility:

- Individuals at least 18 years of age who have been admitted to a hospital with a diagnosed or suspected traumatic brain injury within the past 48 hours.

Design:

- Participants will have one 3-hour study visits: an initial visit (within 48 hours of head injury). Participants may be asked to have an optional 4-day, 30-day, 90-day, and 1-year follow-up.

- Each visit may involve blood samples, an MRI scan (approximately 30 minutes), and a series of tests to evaluate brain function.

- At the optional follow-up visit, participants may have blood samples, an MRI scan, and a general traumatic brain injury assessment.

- This study does not provide treatment and does not replace any current therapies. However, participants who are eligible for other National Institutes of Health studies may be referred to these studies by researchers.

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Eligibility

INCLUSION CRITERIA:

Suspected TBI Subjects

Suspected TBI subjects must meet the following inclusion criteria:

1. History of acute head injury with or suspected non-penetrating acute TBI

2. Age 18 years or older

3. Deemed medically safe for study participation by the subject s attending physician

4. Able to provide consent or have a legally-authorized representative provide consent.

Healthy Volunteers

Healthy volunteers must meet the following inclusion criteria:

1. Healthy without past or present history of TBI or other brain disease, as evaluated by medical history and physical exam

2. Age 18 or older.

3. Able to provide informed consent

EXCLUSION CRITERIA:

Suspected TBI Subjects

Suspected TBI subjects are not eligible for participation in this research study if any of the following conditions exist:

1. Considered to be psychiatrically unstable by the patient s attending physician

2. Contraindication to MRI scanning including: pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments.

3. Conditions precluding entry into the scanner such as morbid obesity or claustrophobia or conditions requiring sedation.

4. In female subjects, pregnancy.

Healthy Volunteers

Healthy volunteers are not eligible for participation in this research study if any of the following conditions exist:

1. Presence of cognitive impairment based on medical history and/or Mini Mental State Examination (MMSE) score of < 27

2. Current or past DSM-IV diagnosis of a psychiatric disorder including substance use disorder as determined by self-report, medical history, and/or clinical exam

3. Major medical problems that can impact brain function (e.g., problems of the CNS including seizures and psychosis; cardiovascular disease including hypertension and arrhythmias; metabolic, autoimmune, endocrine disorders) as determined by self-report, medical history and/or clinical exam;

4. Contraindication to MRI scanning including certain metal implants or devices such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitroglycerine) that cannot be removed for the study, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal imbedded in a subject s body (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near the subject s eyes).

5. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).

6. In female subjects, pregnancy or breastfeeding.

7. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.

Currently phase 1 of enrollment for healthy volunteers in the A Beta PET pilot is complete. At this time enrollment of healthy volunteers is on hold until analysis complete. Enrollment of A Beta PET pilot TBI subjects and healthy matches may resume under Phase-2 if analysis of initial data suggests update


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Citations:

Selassie AW, Zaloshnja E, Langlois JA, Miller T, Jones P, Steiner C. Incidence of long-term disability following traumatic brain injury hospitalization, United States, 2003. J Head Trauma Rehabil. 2008 Mar-Apr;23(2):123-31.

Zaloshnja E, Miller T, Langlois JA, Selassie AW. Prevalence of long-term disability from traumatic brain injury in the civilian population of the United States, 2005. J Head Trauma Rehabil. 2008 Nov-Dec;23(6):394-400.

Pierce CA, Hanks RA. Life satisfaction after traumatic brain injury and the World Health Organization model of disability. Am J Phys Med Rehabil. 2006 Nov;85(11):889-98.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lawrence Latour, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room B1D733
36 Convent Drive
Bethesda, Maryland 20892
(301) 496-0463
latourl@ninds.nih.gov

Anita M. Moses
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room B1D733
10 Center Drive
Bethesda, Maryland 20892
(301) 435-1929
anita.moses@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01132937

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